Detroit Medical News - 2022

Effective January 1, 2023, the Michigan Department of Licensing and Regulatory Affairs, Bureau of Professional Licensing (the “Department”), will begin enforcing the Michigan Public Health Code’s requirement that all prescribers electronically transmit all controlled and non-controlled substance prescriptions directly to a pharmacy of the patient’s choice unless an exception applies (the “e-Prescribing Requirement”).

Overview of the e-Prescribing Requirement

Michigan’s e-Prescribing Requirement is codified at MCL §333.17754a. Prescriptions must now be electronically transmitted in a manner that is HIPAA-compliant and meets certain other criteria specified in the above statute. Typically, medical practices which already electronically transmit prescriptions will not need to take action or make changes to their current practice to comply with the e-Prescribing Requirement, provided that their current system meets the requirements set forth in the above statute. Physicians may wish to contact their e-prescribing vendor to ensure their e-prescribing system complies with the e-Prescribing Requirement.

Physicians who do not currently transmit prescriptions electronically should first consider their options for obtaining e-prescribing equipment or software that complies with the e-Prescribing Requirement and the cost of such equipment or software. Physicians who cannot meet the e-Prescribing Requirement can alternatively apply for a waiver, or limit prescribing to only those circumstances under which an exception applies, as further discussed below.

Exceptions to Michigan’s e-Prescribing Requirement

The Michigan statute defines circumstances under which the e-Prescribing Requirement does not apply, as follows:

• The prescriber has applied for and received a waiver from the Department;
• If electronic transmission is not available due to a temporary technological or electrical failure;
• If the prescriber reasonably believes that electronically transmitting the prescription would make it impractical for the patient to obtain the prescription drug in a timely manner and that the delay would adversely affect the patient's medical condition;
• Certain controlled substances orally prescribed in accordance with MCL §333.7333(3) or (4);
• Prescriptions issued by a prescriber to be dispensed outside of Michigan;
• Prescriptions issued by an out-of-state prescriber to be dispensed by a pharmacy located in Michigan;
• Prescriptions issued and dispensed in the same “health care facility” (as defined in the statute) and the patient uses the drug exclusively in the health care facility;
• Prescriptions that contain content that is not supported by the National Council for Prescription Drug Programs Prescriber/Pharmacist Interface SCRIPT Standard;
• If the prescription is for a drug for which the FDA requires the prescription to contain content that cannot be transmitted electronically;
• Prescriptions issued under circumstances in which the prescriber is not required to include on the prescription a name of a patient for whom the prescription is issued including, but not limited to, a prescription issued under MCL §333.5110;
• Prescriptions issued under a research protocol;
• Prescriptions dispensed by a dispensing prescriber;
• Prescriptions for a dialysis-related drug that is administered as part of or incident to a home-based dialysis treatment; or
• Prescriptions issued by a licensed veterinarian.

If a prescriber has not been granted a waiver from the Department and writes a prescription that is not electronically transmitted in reliance on one of the above exceptions, the prescriber must document the applicable exception relied upon by the prescriber for that prescription and provide that documentation to the Department on request.

e-Prescribing Requirement Waiver Process

Physicians who seek to apply for a waiver must complete and submit an application on a form created by the Department. In addition, the applicant must provide evidence that satisfies either of the following requirements:

• The prescriber has received a waiver of the Medicare requirement for electronic transmission of controlled substance prescriptions from CMS (not available until calendar year 2024); or
• The prescriber is unable to meet the e-Prescribing Requirement and also meets one (1) of the following:
  • The prescription is dispensed by a dispensing prescriber;
  • The prescriber demonstrates economic hardship or technological limitations that are not within the control of the prescriber;
  • The prescriber issues prescriptions from a non-profit charitable medical clinic; or
  • The prescriber demonstrates by attesting to exceptional circumstances, including, but not limited to:
    • (Controlled substances only) Prescribing fewer than 100 controlled substances prescriptions per year or the number of controlled substances prescriptions used in the CMS Waiver, whichever is more;
    • Intention to cease practice within the next twelve months; or
    • Limited practice due to an illness or other unforeseen event.

If a prescriber obtains a waiver from the Department, the waiver is valid for 2 years and can be renewed by application to the Department.

What Physicians Should Know About the e-Prescribing Requirement

Michigan’s e-Prescribing Requirement applies regardless of the number of prescriptions issued per year or if the prescriber is retired or in active practice. If a physician cannot meet the e-Prescribing Requirement and writes a limited number of prescriptions each year, the physician may wish to consider applying for a waiver. Physicians who do not prescribe medications at all (whether due to retirement or otherwise) do not have to comply with the e-Prescribing Requirement and do not need to apply for a waiver. The Department has clarified that the e-Prescribing Requirement only applies when writing prescriptions.

Sanctions for Violations of the e-Prescribing Requirement

If a physician issues a prescription in violation of the e-Prescribing Requirement, the physician may be subject to disciplinary action and sanctions, including a fine of not more than $250.00 per violation.

Read Kathleen’s complete article on page 6 in the Fourth Quarter 2022 edition of the Detroit Medical News.